Safety and Efficacy of Andecaliximab in Participants With Moderately to Severely Active Crohn's Disease

Summary

This study will primarily evaluate the safety and efficacy of andecaliximab in adults with active Crohn's disease. The study will consist of a Double-Blind Phase of 8 weeks followed by an Open-Label Extension. Participants who complete the Double-Blind Phase will be eligible to enroll in the optional Open-Label Extension for an additional 44 weeks. Participants who complete Week 52 assessments will be eligible to enter the Extended Treatment Phase to continue treatment with andecaliximab for an additional 156 weeks.

Timeline

Start

2015-04-30

Primary completion

2016-11-30

Completion

2016-12-22

Outcome

Missed primary endpoint

paper Proportions of patients receiving andecaliximab were not different from proportions of patients receiving placebo based on clinical and endoscopic response PMID 29846530 ↗

paper Eight weeks of induction treatment with 150 mg andecaliximab Q2W, 150 mg andecaliximab QW, or 300 mg andecaliximab QW in patients with Crohn's disease did not induce a clinically meaningful symptomatic or endoscopic response. PMID 29846530 ↗

Publications

• Results Schreiber S, Siegel CA, Friedenberg KA, Younes ZH, Seidler U, Bhandari BR, Wang K, Wendt E, McKevitt M, Zhao S, Sundy JS, Lee SD, Loftus EV. A Phase 2, Randomized, Placebo-Controlled Study Evaluating Matrix Metalloproteinase-9 Inhibitor, Andecaliximab, in Patients With Moderately to Severely Active Crohn's Disease. J Crohns Colitis. 2018 Aug 29;12(9):1014-1020. doi: 10.1093/ecco-jcc/jjy070.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Andecaliximab	Monoclonal antibody	150 mg	Subcutaneous
Subject	Andecaliximab	Monoclonal antibody	300 mg	Subcutaneous

Indications